Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT05300906
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2022-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of Engagement-based Personalization of a Digital Mental Health Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants will not be informed about their randomized condition (personalized or non-personalized), but it is likely that they will infer it from the intervention that they receive.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'participants are randomized to either the personalized or the non-personalized intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-07', 'studyFirstSubmitDate': '2022-03-03', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 3 weeks.', 'timeFrame': 'baseline, 3 weeks', 'description': "Wellbeing will be measured in an online survey, using the Mental Health Continuum Short Form. This validated scale consists of 14 items. The scale's total scores range from 14 to 84, with higher scores indicating higher wellbeing and thus better outcomes."}, {'measure': 'Change from baseline in depressive symptoms, measured with the Patient Health Questionnaire-9, at 3 weeks.', 'timeFrame': 'baseline, 3 weeks', 'description': "Depressive symptoms will be measured in an online survey, using the Patient Health Questionnaire-9. This validated scale consists of 9 items. The scale's total scores range from 0 to 27, with higher scores indicating higher depressive symptoms and thus worse outcomes."}, {'measure': 'Change from baseline in anxiety symptoms, measured with the Generalized Anxiety Disorder 7-item scale, at 3 weeks.', 'timeFrame': 'baseline, 3 weeks', 'description': "Depressive symptoms will be measured in an online survey, using the Generalized Anxiety Disorder 7-item scale. This validated scale consists of 6 items. The scale's total scores range from 0 to 21, with higher scores indicating higher anxiety symptoms and thus worse outcomes."}], 'secondaryOutcomes': [{'measure': 'Adherence', 'timeFrame': 'after 3 weeks', 'description': 'Number of modules completed'}, {'measure': 'Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.', 'timeFrame': 'after 1 day', 'description': 'Engagement will be measured within the intervention, with the validated TWente Engagement with Ehealth Technologies Scale. This is a 9 item scale, with a total score ranging from 0 to 36, with higher scores indicating higher engagement and thus better outcomes.'}, {'measure': 'Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.', 'timeFrame': 'after 7 days', 'description': 'Engagement will be measured within the intervention, with the validated TWente Engagement with Ehealth Technologies Scale. This is a 9 item scale, with a total score ranging from 0 to 36, with higher scores indicating higher engagement and thus better outcomes.'}, {'measure': 'Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.', 'timeFrame': 'after 3 weeks', 'description': 'Engagement will be measured within the intervention, with the validated TWente Engagement with Ehealth Technologies Scale. This is a 9 item scale, with a total score ranging from 0 to 36, with higher scores indicating higher engagement and thus better outcomes.'}, {'measure': 'Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 8 weeks.', 'timeFrame': 'baseline, 8 weeks', 'description': "Wellbeing will be measured in an online survey, using the Mental Health Continuum Short Form. This validated scale consists of 14 items. The scale's total scores range from 14 to 84, with higher scores indicating higher wellbeing and thus better outcomes."}, {'measure': 'Change from baseline in depressive symptoms, measured with the Patient Health Questionnaire-9, at 8 weeks.', 'timeFrame': 'baseline, 8 weeks', 'description': "Depressive symptoms will be measured in an online survey, using the Patient Health Questionnaire-9. This validated scale consists of 9 items. The scale's total scores range from 0 to 27, with higher scores indicating higher depressive symptoms and thus worse outcomes."}, {'measure': 'Change from baseline in anxiety symptoms, measured with the Generalized Anxiety Disorder 7-item scale, at 8 weeks.', 'timeFrame': 'baseline, 8 weeks', 'description': "Depressive symptoms will be measured in an online survey, using the Generalized Anxiety Disorder 7-item scale. This validated scale consists of 6 items. The scale's total scores range from 0 to 21, with higher scores indicating higher anxiety symptoms and thus worse outcomes."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Well-being']}, 'descriptionModule': {'briefSummary': 'This study will investigate the effectiveness of an engagement-based personalized 2-week mobile wellbeing intervention, vs the effectiveness of a non-personalized 2-week mobile wellbeing intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least mild depressive or anxiety complaints; \\>4 Generalized Anxiety Disorder 7-item scale OR Patient Health Questionnaire 9-item scale\n* access to smartphone with internet\n* adequate English literacy\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05300906', 'briefTitle': 'The Effectiveness of Engagement-based Personalization of a Digital Mental Health Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Twente'}, 'officialTitle': 'The Effectiveness of Engagement-based Personalization of a Two-week Digital Mental Health Intervention Targeting Wellbeing: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Personalization Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personalized', 'description': 'Participants in the personalized arm will receive the optimal combination of content, feedback and design, based on their baseline engagement scores.', 'interventionNames': ['Behavioral: personalized 2-week mobile wellbeing intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-personalized', 'description': 'Participants in the non-personalized arm will receive a randomly selected version of the 27 possible interventions, regardless of their baseline engagement scores.', 'interventionNames': ['Behavioral: non-personalized 2-week mobile wellbeing intervention']}], 'interventions': [{'name': 'personalized 2-week mobile wellbeing intervention', 'type': 'BEHAVIORAL', 'description': 'For the study, 27 versions of a 2-week mobile wellbeing intervention are created. These versions vary on content (Cognitive Behavioral Therapy, meaning, positive psychology), feedback (text, text with avatar, pre-recorded video) and design (non-gamified, competitively gamified, storyline gamified). At baseline, participants preview all variations and indicate their expected engagement. Participants in the personalized condition will receive the optimal combination of content, feedback and design, based on their baseline engagement scores.\n\nEach version of the intervention consists of a module per day. Each module contains psychoeducation and exercises based on content of the version. Moreover, each module contains pre-specified general feedback and supportive messages.', 'armGroupLabels': ['Personalized']}, {'name': 'non-personalized 2-week mobile wellbeing intervention', 'type': 'BEHAVIORAL', 'description': 'For the study, 27 versions of a 2-week mobile wellbeing intervention are created. These versions vary on content (Cognitive Behavioral Therapy, meaning, positive psychology), feedback (text, text with avatar, pre-recorded video) and design (non-gamified, competitively gamified, storyline gamified). At baseline, participants preview all variations and indicate their expected engagement. Participants in the non-personalized condition will receive a random version of the intervention.\n\nEach version of the intervention consists of a module per day. Each module contains psychoeducation and exercises based on content of the version. Moreover, each module contains pre-specified general feedback and supportive messages.', 'armGroupLabels': ['non-personalized']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Enschede', 'country': 'Netherlands', 'facility': 'University of Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}], 'overallOfficials': [{'name': 'Saskia M Kelders, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Twente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The plan is to share anonymized data from the study in a open science database. Specifics are not yet established.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Twente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Saskia Kelders', 'investigatorAffiliation': 'University of Twente'}}}}